Safety IssuesEarly Phase 1NCT03163212
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
A Early Phase 1 study testing Lactoferrin/FOS in people with Safety Issues and Tolerance, run by University of Virginia.
Trial summary
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Safety Issues, Tolerance, Very Low Birth Weight Infant
- What is being tested?
- Lactoferrin/FOS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- < 15 days of age and receiving enteral feedings
- < 1500 grams birth weight
- < 37 weeks gestation
Who cannot join
- Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
- Known necrotizing enterocolitis or bowel perforation
Trial locations and contacts
No sites are listed yet.
About this study
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.
Read the detailed description
Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants
- Lactoferrin/FOS related adverse events and serious adverse events
- Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin/FOS absorption and excretion
- Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
- Examine lactoferrin levels in materal and human donor milk
Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure
- Conditions
- Safety Issues, Tolerance, Very Low Birth Weight Infant
- Being tested
- Lactoferrin/FOS
- Keywords
- Lactoferrin/FOS Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin/FOSDietary supplement
Also called BF100
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin/FOS 100mg/kg | Experimental | 100 mg/kg enteral administration daily for 30 days Receives: Dietary Supplement: Lactoferrin/FOS |
| Lactoferrin/FOS 200mg/kg | Experimental | 200 mg/kg enteral administration daily for 30 days Receives: Dietary Supplement: Lactoferrin/FOS |
| Lactoferrin/FOS 300mg/kg | Experimental | 300 mg/kg enteral administration daily for 30 days Receives: Dietary Supplement: Lactoferrin/FOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Definitely related study solution serious adverse event
Measured: 30 days while receiving study solution
Secondary outcomes (2)
Day after birth to reach 120ml/kg of enteral feeds
Measured: 30 days while receiving study solution
Number of days not receiving any feedings after lactoferrin/FOS administration
Measured: 30 days while receiving study solution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startJun 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation design
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, David A Kaufman, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163212
- Sponsor's protocol ID
- 19804
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Specimens which have been unidentified may be shared with outside labs for analysis
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT03163212
- Acronym / sponsor ID
- 19804
- Conditions
- Safety Issues, Tolerance, Very Low Birth Weight Infant
- Keywords
- Lactoferrin/FOS Supplementation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Jun 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.
Detailed description
Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants
- Lactoferrin/FOS related adverse events and serious adverse events
- Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
- Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated
Aim 2: To evaluate lactoferrin/FOS absorption and excretion
- Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
- Examine lactoferrin levels in materal and human donor milk
Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin/FOS 100mg/kg | Experimental | Dietary Supplement: Lactoferrin/FOS100 mg/kg enteral administration daily for 30 days |
| Lactoferrin/FOS 200mg/kg | Experimental | Dietary Supplement: Lactoferrin/FOS200 mg/kg enteral administration daily for 30 days |
| Lactoferrin/FOS 300mg/kg | Experimental | Dietary Supplement: Lactoferrin/FOS300 mg/kg enteral administration daily for 30 days |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- < 15 days of age and receiving enteral feedings
- < 1500 grams birth weight
- < 37 weeks gestation
Key exclusion criteria (2 listed)
- Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
- Known necrotizing enterocolitis or bowel perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin/FOSAlso: BF100Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water | Dietary supplement | Lactoferrin/FOS 100mg/kg, Lactoferrin/FOS 200mg/kg, Lactoferrin/FOS 300mg/kg |
Primary outcome
Definitely related study solution serious adverse event
Time frame: 30 days while receiving study solution
2 secondary outcomes
Day after birth to reach 120ml/kg of enteral feeds
Time frame: 30 days while receiving study solution
Number of days not receiving any feedings after lactoferrin/FOS administration
Time frame: 30 days while receiving study solution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Individual participant dataSharing planned: Undecided. Specimens which have been unidentified may be shared with outside labs for analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lactoferrin/FOS in people with Safety Issues and Tolerance, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David A Kaufman, MD (434-924-5428, dak4r@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definitely related study solution serious adverse event (time frame: 30 days while receiving study solution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.